Subsection 5: Medicinal products for which prescription is reserved for certain specialist doctors.

A medicinal product may only be classified as a prescription-only medicine if the restrictions on prescribing are justified by the constraints involved in implementing the treatment, having regard to the specific nature of the pathology and the pharmacological characteristics of the medicinal product, its degree of innovation, or another public health reason.

Classification in the category of medicinal products for which prescription is reserved for certain specialist doctors has the following effects: 1° The prescription or initial prescription of the medicinal product is reserved for doctors who have been awarded a specialist qualification under the conditions set out in decree no. 2004-252 of 19 March 2004 relating to the conditions under which doctors of medicine may obtain a specialist qualification; 2° In…

The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescription framework under III of article L. 5121-12-1 or the import authorisation for the medicinal product may, depending on its characteristics, set a time limit after which the initial prescription lapses and may no longer be renewed by persons other than…